Point of Care Diagnostic for Improved Tuberculosis Testing

Patient with Doctor
Opportunity

Available for Licensing
TRL: 2

IP Status

US Utility Patent Pending (Not Yet Published)

Inventors

Chuck Henry
Delphi Chatterjee

At A Glance

Researchers at Colorado State University have developed a straightforward paper treatment to immobilize proteinase K onto paper-based testing strips to enable an accurate point-of-care diagnostic for the detection of active tuberculosis infection without the use of laboratory intervention to pretreat patient samples.

Advantages of such paper-based tests, include low-cost, ease of fabrication, wide availability, and self-wetting, make it an ideal substrate for sensors for the developing world. In addition, the novel immobilization strategy developed here can be beneficial to almost all  enzyme  properties,  such  as  activity,  specificity,  selectivity,  reduction  of  inhibition  and  aforementioned stability.

For more details, please contact our office!

Licensing Director

Steve Foster
Steve.Foster@colostate.edu
970-491-7100

Reference No.:  2021-083

Background

While an estimated quarter of the world is latently infected with Mycobacterium Tuberculosis (Mtb), active Tuberculosis (TB) is caused by uncontrolled infection leading to a predominantly respiratory and transmissible disease.

According to the recent WHO report, globally, 7.1 million people with TB were reported to have been diagnosed in 2019 – a small increase from 7.0 million in 2018 but a large increase from 6.4 million in 2017 and 5.7–5.8 million annually in the period 2009–2012. In 2020, the COVID-19 pandemic has already had a negative impact on access to TB diagnosis and treatment and will continue beyond 2021.

A Point-of-care (POC) test that readily detects active TB would reduce diagnostic delays, interrupt transmission with appropriate therapy, and address many of the current gaps in global TB control. And although POC diagnostic devices do exist, incidentally,  background  interference is one of the most critical issues in developing sensitive POC assays for TB diagnosis, as the analyte concentration is low in a majority of the population.

Technology Overview

A simple and economical method was developed for using immobilized proteinase K (ProK), a protease used to reduce background, onto paper strips (IPK test strips) to pretreat urine samples.

Testing and stability of the IPK test strips was first performed to ensure ProK immobilization onto the paper. Further testing was done to verify detection of tuberculosis on previously analyzed archived clinical urine samples with known tuberculosis and HIV status.

The results of IPK treated samples were not only consistent with other diagnostic tests, but also much faster. Thus, the urine LAM test developed here has the potential to reach adult and pediatric patients regardless of HIV status or site of infection, and to facilitate global TB control to improve assay performance and ultimately treatment outcomes.

By incorporating the pretreatment into a ready-to-use paper test strip, this paper-based method is a simplified, rapid, shelf-stable and cost-effective surveillance tool with comparable sensitivity to standard testing and presents an advantage for point-of-care testing and detection globally.

Benefits
  • Ready-to-use, Room temperature, shelf-stable testing strips
  • Advantageous for remote areas and developing countries
  • Cost-effective enhanced pretreatment of sample
  • Does not require instrumentation or training laboratory personnel
  • Comparable sensitivity to standard testing
Applications
  • Point-of-care Detection of active tuberculosis from urine or serum
  • Immobilization strategy can be used to decrease background in other POC tests
Last updated: January 2022
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Charles Henry